Feliza Mirasol

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.

Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.

Phase 3 cancer vaccines and rare disease programs are positioning mRNA therapeutics beyond COVID-19, expanding precision treatment opportunities across oncology and genetic disorders.

FDA has approved Organon's tocilizumab-bavi (Tofidence) for CAR T-cell–induced CRS and hospitalized COVID-19 in adults and children aged 2 years or older.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

Phase 3 data from Boehringer Ingelheim’s SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials meet their primary endpoints, with glucagon/GLP-1 dual agonism showing targeted metabolic fat reduction beyond body weight loss at 76 and 48 weeks.

The approval is based on phase 3 non-inferiority data from the IRAKLIA study, making isatuximab the first anticancer therapy administered via an on-body injector in the EU.

AI-driven protein design, continuous-learning R&D platforms, mechanistic PK/PD modeling, and automated analytical workflows are now foundational tools reshaping how biopharmaceuticals are discovered, characterized, and delivered.

Made Scientific and Pluristyx will integrate iPSC starting materials with CDMO services for cell therapy development.

Agilent’s Dr. Ganesh Bala explains how MAM-based LC–MS peptide mapping has become a foundational analytical tool for ADC and bioconjugate CQA monitoring in this Q&A piece.

CytomX and Regeneron aim to deepen their joint effort to develop protease-activated bispecific immunotherapies designed to improve tumor selectivity and widen the therapeutic window in solid tumors.

Flexible laboratory and good manufacturing practice-ready infrastructure in Basel is designed to support biopharma startups, manufacturing scale-up, and innovation growth, says SENN Development CEO Dr. Johannes Eisenhut.

Dual primary endpoints were met in both PANKU-Breast02 and PANKU-Esophagus01 phase 3 trials based on interim analyses, while priority review is underway for the esophageal cancer indication in China, Bristol Myers Squibb and Biokin stated.

BioNTech and Bristol Myers Squibb report confirmed ORRs exceeding 60% at the lower dose in both non-squamous and squamous first-line NSCLC; three global Phase 3 trials are now enrolling.

Fosun Pharma has dosed the first participant in a mainland China trial of FXB0871, as a parallel phase 1 study continues in the United States and Canada under Teva's TEV-56278 designation

Biohub has released an open-source AI protein design model aimed at early drug discovery, with initial testing in cancer and immune targets.

SENN Development CEO Dr. Johannes Eisenhut discusses how Basel’s expanding life sciences ecosystem supports biopharma innovation through research infrastructure and specialized talent growth.

New analysis of phase 3 data shows Sobi's olezarsen reduced acute pancreatitis events and triglycerides in a pooled CORE/CORE2 subgroup with severe hypertriglyceridemia.

Charles River Laboratories’ Dr. Alan K. Smith explains how early commercial planning, modular manufacturing, and AI-driven automation may accelerate scalable manufacturing for cell and gene therapies.

TreeFrog Therapeutics reports that TFG-001 preclinical data suggest early dopamine release and graft-derived reinnervation in Parkinson disease models.

Risk-based ADC cleaning validation must integrate degradation profiling, HBEL-aligned analytical methods, and dual large/small molecule strategies for facility safety, according to STERIS technical services director, Paul Lopolito.

The Phase 3 CANOPY-HCH-3 data show statistically significant gains in annualized growth velocity, standing height, and arm span at 52 weeks; regulatory filings planned for Q3 2026.

Avaí Bio and Austrianova have completed a GMP master cell bank for an early-stage α-Klotho cell therapy program.

Dr. Edwin Stone, CEO of Cellular Origins, emphasizes that scalable manufacturing must support, not limit, development of safe and effective biological therapies like cell therapies while speaking at the 2026 ASGCT Annual Meeting.

Updated RestorAATion-2 data show durable M-AAT restoration and Z-AAT reduction across biweekly and monthly dosing regimens, with FDA accelerated approval pathway feedback anticipated mid-2026

Cell therapy developers are prioritizing scalable manufacturing strategies alongside efficacy to support broader commercial deployment, notes Cellular Origins CEO Dr. Edwin Stone at the 2026 ASGCT Annual Meeting.

Hansa Biopharma’s licensing agreement with SERB will support expanded commercialization of imlifidase (Idefirix) for highly sensitized kidney transplant patients across Europe and MENA.

FDA’s approval of Immgolis and Immgolis Intri introduces the first golimumab biosimilars for rheumatoid arthritis and ulcerative colitis in the United States.

Through a Series B financing, CREATE Medicines will support clinical advancement of its in vivo CAR-T candidates for autoimmune disease and oncology indications.

Certara UK’s Dr. Armin Sepp, who spoke at the 2026 AAPS National Biotechnology Conference, explains how quantitative systems pharmacology may improve CAR T-cell safety and efficacy by modeling immune activation, tumor response, and cell persistence.